GUDID 04719873695676

Canister for VT• One - 150ml luer lock

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system pump, electric
Primary Device ID04719873695676
NIH Device Record Key7c39d5bc-9c0c-4a32-a28f-c3ceee606e02
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS1004-6030
Company DUNS658863238
Company NameCARILEX MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719873695669 [Primary]
GS104719873695676 [Package]
Contains: 04719873695669
Package: [5 Units]
In Commercial Distribution
GS104719873695683 [Package]
Package: [8 Units]
In Commercial Distribution
GS114719873695666 [Package]
Contains: 04719873695669
Package: [5 Units]
In Commercial Distribution
GS124719873695663 [Package]
Contains: 14719873695666
Package: [10 Units]
In Commercial Distribution

FDA Product Code

KDQBottle, Collection, Vacuum

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-24
Device Publish Date2021-03-16

Devices Manufactured by CARILEX MEDICAL, INC.

04719873696901 - NA2024-06-28 TheraFlo 9 M-set 36" x 80" WDTX Carilex
14719873696915 - NA2024-06-28 TheraFlo 9 Cover 36" x 80" WDTX Carilex-1p
04719873696925 - NA2024-06-28 TheraFlo 9 M-set 42" x 80" DTX Carilex
14719873696939 - NA2024-06-28 TheraFlo 9 Cover 42" x 80" DTX Carilex-1p
04719873696949 - NA2024-06-28 FIT M-Set 36" x 80" VTX Carilex
04719873696956 - NA2024-06-28 FIT M-Set 36" x 80" WDTX Carilex
04719873696963 - NA2024-06-28 FIT M-set 36" x 80" QLT Carilex
04719873696970 - NA2024-06-28 FIT M-Set 42" x 80" VTX Carilex

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